First-Line and Neoadjuvant Immunotherapy for Gastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorQilu Hospital of Shandong University
About this trial
This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes
Eligibility criteria
Qualifiers
Age 18 years old or above
Patients with advanced gastric cancer or locally advanced gastric cancer
Have not received any previous anti-tumor therapy
Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
Disqualifiers
Patients with contraindications to immunotherapy
Have received anti-tumor treatments such as immunotherapy and chemotherapy
Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases
Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment
Trial design
Treatments tested in this trial
- ICI plus Chemothearpy
- Chemotherapy
Treatment groups
500 Participants
are divided into 2 treatment groupsLocations
1Qilu Hospital of Shandong University250012, JinanShandong, China
Sponsors and collaborators
Qilu Hospital of Shandong University
Lead sponsor
Source ClinicalTrials.gov